Program is subject to change.
Workshop Pretest
Completed online between Saturday, July 23 and Sunday, July 24
SUNDAY, JULY 24
Shuttles from Denver International Airport
11:30 am-2:00 pm / 12:30 pm-3:00 pm / 1:15 pm-3:45 pm
Registration
1:30 pm-5:30 pm
Faculty Meeting
4:45 pm-5:30 pm
Welcome/Overview
5:30 pm-5:45 pm
Manuel Hidalgo, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York
Opening Keynote Lecture
Session Chair: Manuel Hidalgo, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York
5:45 pm-6:30 pm
William G. Kaelin, Dana-Farber Cancer Institute, Boston, Massachusetts
Dinner
6:30 pm-7:15 pm
Protocol Development Group Session
6:30 pm-9:00 pm
MONDAY, JULY 25
Breakfast
7:00 am-8:00 am
Lecture Session 1
Session Chair: Julie M. Vose, University of Nebraska Medical Center, Omaha, Nebraska
8:00 am-10:00 am
- Clinical Trial Design: Asking Important Questions that Impact Our Patients
Julie M. Vose, University of Nebraska Medical Center, Omaha, Nebraska - Answering Important Questions: From Hypothesis to Analysis
Thomas M. Braun, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan - Phase I Trial Questions
Manuel Hidalgo, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York - Phase I Trial Designs
Nolan M. Wages, Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia
Questions / Panel Discussion
Break
10:00 am-10:20 am
Lecture Session 2
Session Chair: Mary W. Redman, Fred Hutchinson Cancer Research Center, Seattle, Washington
10:30 am-12:45 pm
- Phase II Trial Questions/Objectives
Maha Hussain, Northwestern University Feinberg School of Medicine, Chicago, Illinois - Phase II Trial Designs
Sean Devlin, Memorial Sloan Kettering Cancer Center, New York, New York - Novel Trial Designs
Mary W. Redman, Fred Hutchinson Cancer Research Center, Seattle, Washington - Drug Combination Trials
Yelena Janjigian, Memorial Sloan Kettering, New York, New York - Multimodality Trials
Karyn Goodman, Icahn School of Medicine at Mount Sinai, New York, New York
Questions / Panel Discussion
Lunch (boxed)
12:45 pm-1:30 pm
Protocol Development Group 2
1:30 pm-4:00 pm
Independent Study Time
4:00 pm-7:00 pm
Office Hours 1 (Biostatisticians; appointments will be scheduled by PDG faculty)
4:30 pm-6:30 pm
ASSIGNMENT DUE: PROTOCOL TEMPLATE
7:00 pm
Dinner
7:00 pm-9:00 pm
TUESDAY, JULY 26
Breakfast
7:00 am-8:00 am
Special Lecture
8:00 am-8:30 am
Career Development Opportunities: The Government Can Help
Oliver Bogler, National Cancer Institute, Rockville, Maryland
Lecture Session 3
Session Chair: Wendy B. London, Boston Children’s Hospital/Dana-Farber Cancer Institute Boston, Massachusetts
8:30 am-10:00 am
- Feasibility and Reproducibility in Biomarker Studies
Kurt A. Schalper, Yale University, New Haven, Connecticut - Incorporation of Biological Correlative Studies into Early Clinical Trials
Timothy A. Yap, The University of Texas MD Anderson Cancer Center, Houston, Texas - Statistical Aspects of Correlative Studies
Wendy B. London, Boston Children’s Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts
Questions / Panel Discussion
Break
10:00 am-10:30 am
Lecture Session 4
Session Chair: Ezra Cohen, UCSD Moores Cancer Center, La Jolla, California
10:30 am-12:00 pm
- Imaging in the Era of Targeted Therapy and Immunotherapy
Thomas E. Yankeelov, The University of Texas, Austin, Texas - Special Considerations in the Design of Immunotherapy Studies
Alex A. Adjei, Cleveland Clinic, Cleveland, Ohio - Inflammatory and Immunologic Biomarkers
Ezra Cohen, UCSD Moores Cancer Center, La Jolla, California
Questions / Panel Discussion
Lunch (boxed)
12:00 pm-12:45pm
Protocol Development Group Session 3
12:45 pm-3:45 pm
Break
3:45 pm-4:00 pm
Office Hours 2: Protocol Related Questions
4:00 pm-6:00 pm
Independent Study Time
3:45 pm-7:00 pm
Pizza and salads available from 5:00 pm-7:00 pm
ASSIGNMENT DUE: STATISTICAL DESIGN
7:00 pm
WEDNESDAY, JULY 27
Breakfast
7:00 am-8:00 am
Small Group Discussion Sessions 1-3
8:00 am-9:00 am
- Artificial Intelligence
Thomas E. Yankeelov, The University of Texas, Austin, Texas - Palliative Care and Quality of Life
Dawn L. Hershman, Herbert Irving Comprehensive Cancer Center of Columbia University, New York, New York
Shing Lee, Columbia University, New York, New York
Patient Advocate to be announced - Phase III Trials
Lindsay Renfro, University of Southern California, Los Angeles, California
Elizabeth Plimack, Fox Chanse Cancer Center, Philadelphia, Pennsylvania
Patient Advocate to be announced
Break
9:00 am-9:15 am
Small Group Discussion Sessions 4-6
9:15 am-10:15 am
- Navigating the National Clinical Trials Network
Speaker to be announced
Vijay Bhatt, Univeristy of Nebraska Medical Center, Omaha, Nebraska
- Incorporation of Digital Health and PROs
Karyn Goodman, Icahn School of Medicine at Mount Sinai, New York, New York
Sujata Patil, The Cleveland Clinic, Cleveland, Ohio
Patient Advocate to be announced
- Laboratory Correlates
Elizabeth G. Hill, Hollings Cancer Center at the Medical University of South Carolina, Charleston, South Carolina
Ruth O’Regan, University of Rochester, Rochester, New York
Kurt A. Schalper, Yale University, New Haven, Connecticut
Break / Group Photo
10:15 am-10:30 am
Small Group Discussion Sessions 7-9
10:30 am-11:30 am
- Defining, Identifying, and Knowing Your Trial’s Clinical Endpoints
John Byrd, University of Cincinnati College of Medicine, Cincinnati, Ohio
Chen Hu, Johns Hopkins University, Baltimore, Maryland
Patient Advocate to be announced
- First in Human Trials: Understanding the Regulatory Process
Franklin Smith, Medpace, Cincinnati, Ohio
Douglas Yee, Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota
- Large-Scale Genomic Analysis: Bench to Bedside
Manish Shah, Weill Cornell Medical College, New York, New York
Tim Yap, The University of Texas MD Anderson Cancer Center, Houston, Texas
Lunch
11:30 am-12:30 pm
Lecture Session 5
Session Chair: Thomas Braun, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan
12:30 pm-2:00 pm
- Leveraging Large Datasets in Clinical Trial Design
Thomas Braun, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan - Barriers to Accrual and How to Overcome Them
Ruth O’Regan, University of Rochester, Rochester, New York - Research Challenges and Lessons Learned in the era of COVID
Laura C. Michaelis, Medical College of Wisconsin, Milwaukee, Wisconsin
Questions / Panel Discussion
Break
2:00 pm-2:15 pm
Protocol Development Group Session 4
2:15 pm-4:15 pm
Independent Study Time/Dinner on Own
4:15 pm-7:00 pm
ASSIGNMENT DUE: PROTOCOL DRAFTS
7:00 pm
THURSDAY, JULY 28
Breakfast
7:00 am-8:00 am
Lecture Session 6
Session Chair: Manish A. Shah, Weill Cornell Medical College, New York, New York
8:00 am-9:40 am
- You’re In Charge: Investigator Responsibilities
Manish A. Shah, Weill Cornell Medical College, New York, New York - How to Pay For Your Trial
Doug Yee, Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota - Everything You Need to Know About Clinical Trial Ethics and Informed Consent: A Case Study
Dawn L. Hershman, Herbert Irving Comprehensive Cancer Center of Columbia University, New York, New York
Ivy B. Elkins, EGFR Resisters, Evanston, Illinois
Patient Advocate to be announced
Questions / Panel Discussion
Break
9:40 am-9:55 am
Lecture Session 7
Session Chair: Mark Krailo, Children’s Oncology Group, Arcadia, California
9:55 am-11:35 am
- Data Collection: It’s All In the Data
Mark Krailo, Children’s Oncology Group, Arcadia, California - Inclusivity in Clinical Trials
Stuart M. Lichtman, Memorial Sloan Kettering Cancer Center, New York, New York
Josh Mailman, NorCal CarciNET Community, Oakland, California
Questions / Panel Discussion
Break
11:35 am-11:45 am
Keynote Lecture
11:45 am-12:35 pm
Monica Bertagnolli, Brigham and Women’s Hospital, Boston, Massachusetts
Lunch
12:35 pm-1:30 pm
Protocol Development Group Session 5
1:30 pm-3:00 pm
Independent Study Time/Dinner on Own
3:00 pm-7:00 pm
Office Hours 3
3:30 pm-5:00 pm
Optional Networking Session: Women in Hematology/Oncology
5:15 pm-6:15 pm
ASSIGNMENT DUE: INFORMED CONSENT DOCUMENTS
7:00 pm
FRIDAY, JULY 29
Breakfast
7:00 am-8:30 am
Faculty Meeting (Faculty Only)
7:30 am-8:30 am
Optional Career Sessions
8:30 am-9:30 am
- Collaborating with Industry
Maura Dickler, Eli Lilly and Company, Indianapolis, Indiana
Franklin O. Smith, Medpace, Cincinnati, Ohio - Careers in Radiation Oncology
Jeff Bogart, State University of New York, Albany, New York
Adam Dicker, Thomas Jefferson University Kimmel Cancer Center, Philadelphia, Pennsylvania - Career Transition Tips
Faculty to be announced
Break
9:30 am-9:45 am
Lecture Session 8
Session Chair: Alex A. Adjei, Cleveland Clinic, Cleveland, Ohio
9:45 am-11:30 am
- Successful Grantsmanship
Dawn L. Hershman, Herbert Irving Comprehensive Cancer Center of Columbia University, New York, New York - Reporting and Presenting Results
Shing Lee, Columbia University, New York, New York
Tari King, Dana-Farber Cancer Institute/Brigham and Women’s Cancer Center, Boston, Massachusetts
Questions / Panel Discussion
Break
11:10 am-11:20 pm
Protocol Development Group Session 6
11:20 am-1:00 pm
Lunch (box)
1:00 pm-1:30 pm
Administration of Post-test
1:30 pm-2:30 pm
Independent Study Time
2:30 pm-7:00 pm
ASSIGNMENT DUE: FINAL PROTOCOLS, INFORMED CONSENT FORMS, and ALL WORKSHOP EVALUATIONS
7:00 pm
Closing Reception / Banquet / Dance
7:00 pm-11:00 pm
SATURDAY, JULY 30
Continental Breakfast
5:00 am-8:00 am
Departure
6:00 am-8:30 am / 7:15 am-9:45 am / 10:00 am-12:30 pm